Double-blind, Randomized, Non-inferiority Phase III Trial on the Efficacy and Tolerability of 2 mg Once Daily vs. 1 mg Twice Daily Budesonide Orodispersible Tablets in Adults With Eosinophilic Esophagitis
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets BID versus 2 mg budesonide orodispesible tabletss for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Signed informed consent,
• Male or female patients, 18 to 75 years of age,
• Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria
• Active symptomatic and histological EoE
• Negative pregnancy test in females of childbearing potential at baseline visit.
Locations
United States
California
Dr. Falk Investigational Site
RECRUITING
La Jolla
Dr. Falk Investigational Site
RECRUITING
Lomita
Louisiana
Dr. Falk Investigational Site
RECRUITING
Houma
Dr. Falk Investigational Site
RECRUITING
Marrero
Massachusetts
Dr. Falk Investigational Site
RECRUITING
Boston
Minnesota
Dr. Falk Investigational Site
RECRUITING
Rochester
North Carolina
Dr. Falk Investigational Site
RECRUITING
Chapel Hill
New Jersey
Dr. Falk Investigational Site
RECRUITING
Freehold
Dr. Falk Investigational Site
RECRUITING
Jackson
Ohio
Dr. Falk Investigational Site
NOT_YET_RECRUITING
Cleveland
Texas
Dr. Falk Investigational Site
RECRUITING
Harlingen
Other Locations
Spain
Department of Gastroenterology, Hospital General de Tomelloso
RECRUITING
Tomelloso
Contact Information
Primary
Sarah Burrack, Dr.
zentrale@drfalkpharma.de
004976115140
Time Frame
Start Date: 2021-05-21
Estimated Completion Date: 2026-06
Participants
Target number of participants: 308
Treatments
Experimental: Arm A
Budesonide 2 mg orodispersible tablet once daily
Active_comparator: Arm B
Budesonide 1 mg orodispersible tablet twice daily
Related Therapeutic Areas
Sponsors
Leads: Dr. Falk Pharma GmbH